FDA Rejects New Painkiller That Contains Opioids, Morphine and Oxycodone

Perhaps due to the current backlash over prescription painkillers in Massachusetts, New Hampshire, Maine, New York, and Ohio, the Food and Drug Administration finally took a hint and rejected a new painkiller that was up for approval.

In a unanimous 14-0 decision, a panel of FDA advisors voted against Moxduo, a powerful opioid intended to be prescribed for fast pain relief. The voters questioned the drug's benefit over exclusively using morphine or oxycodone and did not agree with the "intended benefits" that the drug manufacturer's trials documented.

The reviewers were also concerned with the growing prescription opioid addiction and misuse problem that has occurred across the United States over the past fifteen years. The New England states have expressed immediate concern over the issue in the past month, with Governor Deval Patrick of Massachusetts declaring a state of emergency on the matter. He says he will not allow pharmacies in the state to dispense the newly approved opioid Zohydro, which has been available since March.

QRxPharma is Moxduo's manufacturer, whose company headquarters are located in Australia. The company's stock dropped 80% in Sydney trading following the FDA panel's rejection of the prescription opioid and closed at $0.14 yesterday. Moxduo would have been both QRxPharma's first drug on the market as well as the first prescription pill to contain two opioids. The specialty pharmaceutical company suffered a setback with the rejection, yet still remain confident in the drug's benefits and advantages.

QRxPharma says that Moxduo will decrease respiratory depression compared to other opiates. The FDA panel did not see definitive or evident findings of such claims in the drug manufacturer's studies and trials. Also, addiction researchers and specialists argued that Moxduo could be more easily abused than current prescription opioids, which would create a setback in the current fight against the drug.

"This is pure morphine and pure oxycodone," addiction specialist Dr. Andrew Kolodny of the Phoenix House, in this New York Daily News article. "This is a product that is very easy to misuse. Very easy to crush and snort or crush and inject. So it's significantly more dangerous than the products that it would be competing with."

The FDA hasn't officially made a ruling on the drug's status, but the administration typically follows the decisions arrived at by its panels.